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1.
目的 从患者视角深入了解已完成新辅助免疫治疗临床试验患者在其参与过程中的角色感知和体验,为新辅助免疫治疗方案临床试验设计中增加患者视角,进一步促进新辅助免疫治疗用药的发展及提升我国肿瘤患者的整体诊治水平提供参考和依据。方法 采用现象学研究方法,以目的抽样选取13例已完成新辅助免疫治疗临床试验患者,进行半结构式访谈,并运用Colaizzi7步分析法对资料进行分析。结果 患者参与新辅助免疫治疗临床试验的角色感知归纳为4个主题,分别为药物发展的“试验品”、新药实践的志愿者与促进者、新药方案的参与者与评价者、医学进步的受益者。患者在新辅助免疫治疗临床试验中的参与体验归纳为3个主题,分别为来自研究团队的关怀,新辅助免疫临床试验过程中的担心与困扰(免疫不良反应的不确定性、医疗资源的不便捷性、随访检查的频繁性),医院、社会缺少对临床试验的相关宣传(试验获取途径受限、积极与支持环境的欠缺、尊重与理解的需求)。结论 患者在新辅助免疫治疗临床试验参与中尚需改善其“试验品”的负性感知,参与体验也反映了目前新辅助免疫治疗临床试验中存在的相关问题,护理人员需要重视患者在试验参与中的体验,针对患者需求完善健康教育方案,提升社会支持,进而提高我国新辅助免疫治疗临床试验的质量。  相似文献   
2.
Renal cell cancer (RCC) represents 2%-3% of all adulthood cancers and is the most common malignant neoplasm of the kidney (90%). In the mid-nineties of the last century, the standard of treatment for patients with metastatic RCC was cytokines. Sunititib and pazopanib were registered in 2007 and 2009, respectively, and have since been the standard first-line treatment for metastatic clear cell RCC (mccRCC). Renal cell cancer is a highly immunogenic tumor with tumor infiltrating cells, including CD8+ T lymphocytes, dendritic cells, natural killer cells (NK) and macrophages. This observation led to the design of new clinical trials in which patients were treated with immunotherapy. With the growing evidence that proangiogenic factors can have immunomodulatory effects on the host’s immune system, the idea of combining angiogenic drugs with immunotherapy has emerged, and new clinical trials have been designed. In the last few years, several therapeutic options have been approved [immunotherapy and immunotherapy/tyrosine kinase inhibitors (TKI)] for the first-line treatment of mccRCC. Nivolumab/ipilimumab is approved for the treatment of patients with intermediate and poor prognoses. Several checkpoint inhibitors (pembrolizumab, nivolumab, avelumab) in combination with TKI (axitinib, lenvatinib, cabozantinib) are approved for the treatment of patients regardless of their International mRCC Database Consortium prognostic group and PD-L1 expression. There is no specific and ideal biomarker that could help in selecting the ideal patient for the appropriate first-line treatment.  相似文献   
3.
免疫检查点抑制剂的使用重塑了肿瘤的治疗,同时也诱发了免疫相关不良事件,最常见于皮肤、胃肠道、肺、内分泌系统和肝脏。内分泌系统免疫相关不良事件最常见的为甲状腺功能异常和垂体炎,罕见的包括自身免疫型糖尿病、肾上腺功能不全及甲状旁腺功能减退(hypoparathyroidism,HP)。本文报道了1例使用卡瑞利珠单抗后出现HP的案例,并检索国内外相关文献,对其使用药物、性别、年龄、发生时间、临床表现、辅助检查及治疗措施等进行汇总并分析讨论,以期提高对免疫相关HP的识别和管理,减轻药物不良反应对患者造成的伤害,保障用药安全。  相似文献   
4.
 目的 探讨影响1-羟基-2-氧-1,8-萘啶-3-甲酰胺类HIV整合酶链转移抑制剂(integrase strand transfer inhibitors, INSTIs)抗整合酶链转移(integrase strand transfer, INST)活性的主要微观结构因素。方法 采用遗传函数逼近法构建了10个1-羟基-2-氧-1,8-萘啶-3-甲酰胺类INSTIs的二维定量构效关系(2d-quantitative structure-activity relationship, 2D-QSAR)模型,从中优选出最优模型,并据此探析影响抑制剂抗INST活性的主要微观结构因素。结果 最优2D-QSAR模型的非交叉验证相关系数R2为0.8555,留一法交叉验证相关系数Q2loo为0.7761,外部交互验证相关系数R2ext为0.94,表明所建模型具有较好的统计学意义和稳定性。结论 1-羟基-2-氧-1,8-萘啶-3-甲酰胺类INSTIs的抗INST活性主要与描述符JX、Dipole_mag、Jurs_PNSA_1和Strain_Energy相关,可为抑制剂的进一步合理设计提供理论依据。  相似文献   
5.
随着癌症生物学和发病机制研究的不断深入,免疫检查点抑制剂(ICIs)得以问世,为晚期肿瘤患者带来了新的生存希望,从而开启了癌症免疫治疗的新时代,但随着免疫治疗在临床上的广泛应用,免疫相关不良事件(irAEs)也逐渐显现出来,并广泛为一线临床医师所熟知。免疫检查点抑制剂可激活T细胞攻击体内的正常组织和器官,并导致多种不良反应。而免疫检查点抑制剂相关肺炎(CIP)是irAEs中较为罕见且预后较差的并发症之一。本文参考目前国内外相关文献,就部分ICIs的治疗机制及CIP的发病率、危险因素、发生机制、临床表现、影像学表现与CIP的分级及治疗管理作一综述。  相似文献   
6.
BackgroundBailing Capsule (BLC), Jinshuibao (JSB), Huangkui Capsule (HKC), Uremic Clearance Granule (UCG), Tripterygium glycosides (TG), Compound Xueshuantong Capsule (CXC), and Shenyan Kangfu Tablet (SYKFT) as classic Chinese patent medicines (CPMs), have been widely used and shown beneficial effects on the treatment of early diabetic kidney disease (DKD). However, the comparative efficacy of seven CPMs in the treatment of early DKD remains unknown.ObjectiveTo evaluate and compare the efficacy of seven CPMs (BLC, JSB, HKC, UCG, TG, CXC, SYKFT) combined with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) on early DKD by a Bayesian network meta-analysis (NMA) of randomized controlled trials (RCTs).MethodsA comprehensive and systematic literature search was performed in PubMed, Embase, Cochrane Library, Web of Science, Clinical Trials.gov, China Biology Medicine, Chinese National Knowledge Infrastructure, Chinese Scientific Journal, and Wanfang databases from inception to March 14, 2021, for full-text RCTs that evaluated the efficacy of seven CPMs combined with ACEI/ARB on patients with early DKD. Two reviewers independently screened studies for eligibility, extracted data, and assessed the risk of bias. Agreement between reviewers was measured using kappa statistics. Mean difference (MD) and odds ratio (OR) were calculated to evaluate continuous variables and dichotomous, respectively. The random effect modeling NMA was performed and the ranking probability of interventions in various outcomes was also conducted based on the surface under the cumulative ranking curve (SUCRA). Begg’s and Egger’s tests were used to evaluate publication bias. The certainty of the evidence for outcomes was evaluated according to the GRADE system.ResultsA total of 62 RCTs with 5362 patients with early DKD were identified. The value of Kappa calculated for the various parameters extracted by the two investigators was 0.821 (P < 0.001). Among these CPMs, UCG + ACEI/ARB showed the best effectiveness for urinary albumin excretion rate (UAER) (MD 32.25, 95% CrI 19.11–45.67, low certainty) with SUCRA 92%. JSB + ACEI/ARB showed the highest effectiveness for 24-h urinary total protein (24-h UTP) (MD 76.92, 95% CrI 53.54–100.58, low certainty) with SUCRA 97%. CXC + ACEI/ARB showed the highest effectiveness for serum creatinine (SCr) (MD 26.02, 95% CrI 6.10–45.95, low certainty) with SUCRA 96%. HKC + ACEI/ARB showed the highest effectiveness for blood urea nitrogen (BUN) (MD 1.46, 95% CrI 0.42–2.54, very low certainty) with SUCRA 86%. BLC + ACEI/ARB showed significant differences in triglyceride (TRIG) (MD − 1.17, 95% CrI − 1.93 to − 0.43, low certainty) with SUCRA 90%, total cholesterol (TC) (MD − 1.17, 95% CrI − 1.97 to − 0.39, very low certainty) with SUCRA 90%, and C-reaction protein (CRP) (MD − 0.90, 95% CrI − 1.51 to − 0.32, very low certainty) with SUCRA 76%.ConclusionsCPMs + ACEI/ARB might be positive efficacious interventions from which patients with DKD will derive benefit. UCG + ACEI/ARB, JSB + ACEI/ARB, CXC + ACEI/ARB, and HKC + ACEI/ARB might be potentially the preferred intervention for reducing UAER, 24-h UTP, SCr, and BUN levels, respectively. BLC + ACEI/ARB has a better impact on lowing TRIG, TC, and CRP levels in patients with early DKD. However, more high-quality, large-scale, multi-center RCTs and stronger head-to-head trials are required to confirm these findings.  相似文献   
7.
The Dutch Drug Rediscovery Protocol (DRUP) and the Australian Cancer Molecular Screening and Therapeutic (MoST) Program are similar nonrandomized, multidrug, pan-cancer trial platforms that aim to identify signals of clinical activity of molecularly matched targeted therapies or immunotherapies outside their approved indications. Here, we report results for advanced or metastatic cancer patients with tumors harboring cyclin D-CDK4/6 pathway alterations treated with CDK4/6 inhibitors palbociclib or ribociclib. We included adult patients that had therapy-refractory solid malignancies with the following alterations: amplifications of CDK4, CDK6, CCND1, CCND2 or CCND3, or complete loss of CDKN2A or SMARCA4. Within MoST, all patients were treated with palbociclib, whereas in DRUP, palbociclib and ribociclib were assigned to different cohorts (defined by tumor type and alteration). The primary endpoint for this combined analysis was clinical benefit, defined as confirmed objective response or stable disease ≥16 weeks. We treated 139 patients with a broad variety of tumor types; 116 with palbociclib and 23 with ribociclib. In 112 evaluable patients, the objective response rate was 0% and clinical benefit rate at 16 weeks was 15%. Median progression-free survival was 4 months (95% CI: 3-5 months), and median overall survival 5 months (95% CI: 4-6 months). In conclusion, only limited clinical activity of palbociclib and ribociclib monotherapy in patients with pretreated cancers harboring cyclin D-CDK4/6 pathway alterations was observed. Our findings indicate that monotherapy use of palbociclib or ribociclib is not recommended and that merging data of two similar precision oncology trials is feasible.  相似文献   
8.
宫颈癌严重威胁全球女性的生命健康,晚期宫颈癌治疗手段有限,5年生存率不到20%,是妇科肿瘤的巨大挑战。免疫治疗是晚期宫颈癌患者的重要治疗手段之一,包括免疫检查点抑制剂、治疗性疫苗和过继性T细胞免疫疗法等,但免疫治疗耐药性使部分患者无应答而效果不佳。因此,迫切需要深入研究和探讨免疫耐药的机制从而改善耐药,现归纳总结了近年有关宫颈癌中免疫耐药机制的相关研究,主要分为肿瘤内在因素和外在免疫环境改变等因素,并介绍针对免疫耐药提出的应对措施及进展。  相似文献   
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